Blood Glucose Self Monitoring and HbA1c Effects on Glucose Control

Phase 4

Completed

• Conditions: Type 2 Diabetes
• Interventions: Procedure: no blood-glucose self-control; Procedure: weekly blood glucose profile; Procedure: three-monthly haemoglobin A1c

• Registration Number: NCT00688363
• Lead Sponsor: Deutsche Diabetes Gesellschaft

Brief Summary

The purpose of this randomized, prospective trial is to determine wether (a) a once weekly glucose profile (self monitoring) or (b) a three-monthly report of the actual glycated haemoglobin are effective interventions to improve HbA1c after one year in typ 2-diabetic patients on conventional insulin treatment.

Detailed Description

The design is an open, prospective, randomised, multicentre parallel group study. The total duration will be 5 years with patient recruitment over 4 years and an individual observation period of 1 year. 300 participants from 43 study centres, hospitals and private practices were recruited. The study will run for one year and aims to determine, whether there is an advantage with regard to HbA1c levels when (a) a regular three-monthly HbA1c or (b) a weekly 4-point glucose profile is taken and reported.

After screening, patients will be assigned at random to one of the following study arms:

1. no regular blood-glucose self-monitoring, no regular HbA1c

2. regular blood glucose self monitoring, no regular HbA1c

3. no regular blood glucose self monitoring, regular HbA1c

4. regular blood glucose self monitoring, regular HbA1c

The control for all participants is that urinary glucose should be monitored at least once a day, preferably in the late morning, as the highest increase in plasma glucose level occurs after breakfast.

Study Timeline

• Study Start: 2003-02
• Study First Submitted: 2008-05-26
• Study First Submitted QC: 2008-05-30
• Study First Posted: 2008-06-02
• Primary Completion: 2008-09
• Study Completion: 2008-12
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-29
• Last Update Posted: 2011-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Type 2-diabetes (ADA/WHO-Criteria)
• Conventional insulin therapy ( 1-3 daily injections of basal- and/or mixed insulin also in combination with oral agents.)
• Age:> 40 years
• BMI:> 20 kg/m²

Exclusion Criteria

• Impaired liver function, defined as > 2 times upper limit of normal
• Impaired renal function defined liver enzymes as serum-creatinine > 1.3 mg/dl
• Gastro-intestinal diseases (disturbances, diagnoses)
• Inability to perform study-related activities according to the present protocol
• Pregnancy not certainly excluded
• Abuse of alcohol and/or other drugs
• Participation in other clinical trials during the past 3 month
• Threat to general state of health
• Intensified insulin therapy (at least 3 times rapid-acting insulin)
• Frequent blood glucose self monitoring during the past 3 months (more than one 4-point glucose profile per week or more than one blood glucose/ urinary glucose test per day )

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	no blood-glucose self-control	No blood-glucose self-control, no HbA1c
2	weekly blood glucose profile	Blood-glucose self-control, no HbA1c
3	three-monthly haemoglobin A1c	No blood-glucose self-control, HbA1c
3	no blood-glucose self-control	No blood-glucose self-control, HbA1c
4	weekly blood glucose profile	Blood-glucose self-control, HbA1c
4	three-monthly haemoglobin A1c	Blood-glucose self-control, HbA1c

Primary Outcome Measures

Name	Time	Method
Haemoglobin A1c after one year	1 year

Secondary Outcome Measures

Name	Time	Method
a representative blood glucose profile (self monitoring) during the week before the end of the trial	1 year
body weight at the end of the trial	1 year
serum, triglycerides and cholesterol (total HDL as well as LDL-cholesterol) at the end of the trial	1 year
therapy-satisfaction (questionnaire)	1 year
changes of the antidiabetic therapy	1 year
number of hospitalization as a result of hypoglycaemic episodes	1 year
the number of serious hypoglycaemic episodes (hypoglycaemic episodes when the patient needs help from other people)	1 year

Trial Locations

Locations (41)

Krege, Peter; 🇩🇪 Emsdetten, Germany

Fischer, Harald; 🇩🇪 Düren, Germany

Müller, Ulrich. A.; 🇩🇪 Jena, Germany

Pfeiffer, Martha; 🇩🇪 Gronau, Germany

Behnke, Thomas; 🇩🇪 Neuwied, Germany

Maxeiner, Stefan; 🇩🇪 Bad Kreuznach, Germany

Diabeteszentrum Bad Lauterberg; 🇩🇪 Bad Lauterberg, Niedersachsen, Germany

Koch, Peter; 🇩🇪 Bad Harzburg, Germany

Mulch-Wiemer, Christa; 🇩🇪 Bad Nauheim, Germany

Friedrichs, Michael; 🇩🇪 Bad Lauterberg, Germany

Jödicke, Carmen; 🇩🇪 Bad Lauterberg, Germany

Bellmann, Renate; 🇩🇪 Berlin, Germany

Schoch, Daniela; 🇩🇪 Berlin, Germany

Warmers, Ulrike; 🇩🇪 Bitburg, Germany

Leupold, Manfred; 🇩🇪 Borna, Germany

Hildebrandt, Rüdiger; 🇩🇪 Clausthal-Zellerfeld, Germany

Kamke, Wolfram; 🇩🇪 Burg/Sreewald, Germany

Lemmerhirt, Jürgen; 🇩🇪 Cuxhaven, Germany

Weller, Ulrich; 🇩🇪 Dorsten, Germany

Preuß, Uwe; 🇩🇪 Datteln, Germany

Wollersen, Karin; 🇩🇪 Freiburg, Germany

Hendel, Andreas; 🇩🇪 Grassau, Germany

Gölz, Stefan; 🇩🇪 Esslingen, Germany

Jäger, Michael; 🇩🇪 Höchst, Germany

Niemetz, Ingo; 🇩🇪 Kassel, Germany

Grossmann, J.; 🇩🇪 Mönchengladbach, Germany

Kourbanova, Zarema; 🇩🇪 Langenfeld, Germany

Schmitz, Ulrike; 🇩🇪 Krefeld, Germany

Ley, Heinz-Georg; 🇩🇪 Marl, Germany

Willms, Gerhard; 🇩🇪 Leverkusen, Germany

Fueting, Frank; 🇩🇪 Nassau, Germany

Klein, Frank; 🇩🇪 Schenklengsfeld, Germany

Böhme, Rainer; 🇩🇪 Nordhausen, Germany

Rieth-Kunert, Anna; 🇩🇪 Stade, Germany

Naumann, Rainer; 🇩🇪 Schöppenstedt, Germany

Bödecker, A.-W.; 🇩🇪 Wiehl, Germany

Fels, Stefan; 🇩🇪 Oldenburg, Germany

Oerter, Erika-Maria; 🇩🇪 Würzburg, Germany

Nowack, Kirsten; 🇩🇪 Torgau, Germany

Schmidt-Reinwald, Astrid; 🇩🇪 Waldrach, Germany

Füchtenbusch, Martin; 🇩🇪 München, Germany